Balance Training vs. Balance Training w/ STARS

• ClinicalTrials.gov Identifier: NCT01790581
• Recruitment Status: Completed
• First Posted: February 13, 2013
• Results First Posted: December 24, 2014
• Last Update Posted: July 11, 2017
• Sponsor: University of North Carolina, Charlotte
• Collaborator: Mid-Atlantic Athletic Trainers' Association
• Information provided by (Responsible Party): University of North Carolina, Charlotte

Study Description

Brief Summary:

Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains and other residual impairments. CAI has been linked to many different causative factors including sensory and motor deficits that affect the global function of the sensorimotor system as well as the patient. Over the past 20 years, strong evidence has been generated to support balance training as an effective intervention strategy in the CAI population. Unfortunately, most investigations have focused solely on maximizing motor output through balance training, while ignoring the full spectrum of sensorimotor dysfunction associated with CAI. There may be advantageous sensory-targeted interventions that augment the effects of balance training and lead to greater enhancements of functional outcomes for CAI. However, this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation strategies (STARS), such as joint mobilization and plantar massage have resulted in improved sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic resonance) has been investigated in combination with balance training. While the combined effects were greater than those of balance training alone, stochastic resonance requires relatively expensive equipment that is not commercially available. Thus, the purpose of this investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage and joint mobilizations) with balance training will result in greater sensorimotor and functional improvements in those with CAI than balance training alone.

Condition or disease	Intervention/treatment	Phase
Ankle (Ligaments); Instability (Old Injury)	Behavioral: Balance Training; Behavioral: STARS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Balance Training vs. Balance Training w/ STARS
• Study Start Date: January 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Balance Training	Behavioral: Balance Training; This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
Experimental: Balance Training w/ STARS	Behavioral: Balance Training; This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).; Behavioral: STARS; The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques target 3 types of sensory pathways (musculotendinous, articular, and plantar cutaneous, respectively) and will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

Outcome Measures

Primary Outcome Measures :

1. Balance [ Time Frame: Balance at 1-day post intervention ]
   Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
2. Self-assessed Disability [ Time Frame: Disability to 1-day post intervention ]
   2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.

Secondary Outcome Measures :

1. Balance [ Time Frame: Change from baseline balance at 1-week post intervention ]
   Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
2. Self-assessed Disability [ Time Frame: Change from baseline disability at 1-week post intervention ]
   2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
3. Self-assessed Disability [ Time Frame: Change from baseline disability at 1-month post intervention ]
   3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males and females between the ages of 18 and 35.
• A history of at least one episode of "giving way" within the past 3 months.
• Answering 4 or more questions of "Yes" on the Ankle Instability Instrument (AII).
• Score of <90% on the self-reported Foot and Ankle Ability Measure (FAAM).
• Score of <80% on the FAAM Sport.

Exclusion Criteria:

• Failing to meet the inclusion criteria.
• Known balance and vision problems.
• Acute lower extremities and head injuries that occurred <6 weeks ago.
• Chronic musculoskeletal conditions known to affect balance.
• A history of ankle surgeries to fix internal derangements.

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Charlotte

Charlotte, North Carolina, United States, 28223

Sponsors and Collaborators

University of North Carolina, Charlotte

Mid-Atlantic Athletic Trainers' Association

Investigators

• Principal Investigator: Erik A Wikstrom, PhD; University of North Carolina at Charlotte

More Information

Additional Information:

Link to the laboratory in which the research is being conducted 

Publications:

McKeon PO, Ingersoll CD, Kerrigan DC, Saliba E, Bennett BC, Hertel J. Balance training improves function and postural control in those with chronic ankle instability. Med Sci Sports Exerc. 2008 Oct;40(10):1810-9. doi: 10.1249/MSS.0b013e31817e0f92.

• Responsible Party: University of North Carolina, Charlotte
• ClinicalTrials.gov Identifier: NCT01790581
• Other Study ID Numbers: UNCC12-09-16
• First Posted: February 13, 2013
• Results First Posted: December 24, 2014
• Last Update Posted: July 11, 2017
• Last Verified: July 2017

Keywords provided by University of North Carolina, Charlotte:

Chronic Ankle Instability